PMA P030009S102
- Device
- Integrity Coronary Stent System (hereafter called Integrity)
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S102
- Product code
- MAF
- Decision date
- 2021-05-11
- Generic name
- STENT, CORONARY
- Approval order statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.
Current openFDA PMA Record#
- Device
- Integrity Coronary Stent System (hereafter called Integrity)
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S102
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2021-05-11
- Decision code
- OK30
- Date received
- 2021-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.